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SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

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ClinicalTrials.gov Identifier: NCT01451853
Recruitment Status : Not yet recruiting
First Posted : October 14, 2011
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Condition or disease Intervention/treatment Phase
Lung Cancer Head and Neck Cancer Hearing Loss Ototoxicity Tinnitus Neuropathy Drug: SPI-1005 Low Dose Drug: SPI-1005 Middle Dose Drug: SPI-1005 High Dose Drug: Placebo Phase 2

Detailed Description:

Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss
Anticipated Study Start Date : January 15, 2018
Estimated Primary Completion Date : June 26, 2019
Estimated Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: SPI-1005 Low Dose
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 Low Dose

Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Arms: Low Dose

Other Names:

200 mg Ebselen

Other Name: 200 mg Ebselen
Active Comparator: SPI-1005 Middle Dose
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 Middle Dose
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Name: 400 mg Ebselen
Active Comparator: SPI-1005 High Dose
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 High Dose
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Name: 600 mg Ebselen
Placebo Comparator: Placebo
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: Placebo
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Name: 0 mg Ebselen


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Reduction of hearing loss incidence and severity [ Time Frame: From baseline through 1 month after last chemotherapy cycle ]
  2. Reduction of tinnitus incidence and severity. [ Time Frame: From baseline through 1 month after last chemotherapy cycle ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female subjects, 19-80 years of age;
  • Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
  • Voluntarily consent to participate in the study
  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
  • IUD in place for at least 3 months prior to study;
  • Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
  • Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
  • Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
  • Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Exclusion Criteria:

  • Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
  • Presence of alcoholism or drug abuse
  • Participation in another investigational drug or device clinical trial within 30 days prior to the study
  • Female subjects who are pregnant or lactating
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451853


Contacts
Contact: Eric Lynch, PhD (206) 634-2559 elynch@soundpharma.com

Locations
United States, Washington
VA Puget Sound Health Care Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Tony S. Quang, M.D.    206-768-5356      
Principal Investigator: Tony S Quang, M.D.         
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
VA Puget Sound Health Care System
Investigators
Study Director: Jonathan Kil, MD Sound Pharmaceuticals, Inc.
More Information

Publications:
Lynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055

Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT01451853     History of Changes
Other Study ID Numbers: SPI-3005-201
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sound Pharmaceuticals, Incorporated:
Lung Cancer
Head and Neck Cancer
Hearing Loss
Ototoxicity
Tinnitus
Deafness
SPI-1005
Cisplatin
Carboplatin
Ebselen

Additional relevant MeSH terms:
Hearing Loss
Deafness
Head and Neck Neoplasms
Tinnitus
Neoplasms by Site
Neoplasms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ebselen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents